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SARS-CoV-2 Antibodies

CPT: 86769
Updated on 09/22/2020
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Synonyms

  • COVID-19
  • SARS-CoV-2

Expected Turnaround Time

1 - 3 days


Related Documents

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper

For more information, please view the literature below.

Dynamics of SARS-CoV-2 and the Adaptive Immune Response White Paper


Specimen Requirements


Specimen

Serum


Volume

0.8 mL


Minimum Volume

0.7 mL (Note: This volume does not allow for repeat testing.)


Container

Gel-barrier tube, red-top tube or serum transfer tube


Collection

Standard aseptic procedures


Storage Instructions

Room temperature


Stability Requirements

Temperature

Period

Room temperature

3 days (stability determined by manufacturer or literature reference)

Refrigerated

7 days (stability determined by manufacturer or literature reference)

Frozen

28 days (stability determined by manufacturer or literature reference)

Freeze/thaw cycles

Stable x1 (stability determined by manufacturer or literature reference)


Test Details


Use

Qualitative detection of high affinity antibodies to SARS-CoV-2, the virus that causes COVID-19, to aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. This assay enriches detection of higher affinity antibodies which are more likely to be specific for SARS-CoV-2. While this assay in principle can detect high affinity antibodies of all isotypes (i.e., IgG, IgA, IgM), it preferentially detects IgG antibodies since these are more likely to evolve to become high affinity. Serologic results should not be used as the sole basis to diagnosis or exclude recent SARS-CoV-2 infection. This test is recommended for individuals at greater than or equal to 14 days post-symptom onset or following exposure to individuals with confirmed COVID-19.The incubation period for COVID-19 ranges from 5 to 7 days.


Limitations

This test has not been FDA cleared or approved. This test has been authorized by FDA under an Emergency Use Authorization (EUA). This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. This test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. False positive results infrequently occur due to prior infection with other human Coronaviruses.


Methodology

Immunoassay


Additional Information

Current literature suggests that detectable antibodies against SARS-CoV-2 develop approximately 8 to 11 days following onset of symptoms. Correlation with epidemiologic risk factors and other clinical and laboratory findings is recommended. A positive serologic result is not diagnostic but indicates that an individual has likely been infected with SARS-CoV-2 and produced an immune response to the virus. It is not known at this time whether detectable antibody correlates with immunity. A negative serologic result indicates that an individual has not developed detectable antibodies at the time of testing. While contingent on a variety of factors, this could be due to testing too early in the course of infection, the absence of exposure to the virus, or the lack of adequate immune response, which can be due to conditions or treatments that suppress immune function.

FDA-authorized Fact sheets for patients and providers can be accessed at the following link: https://www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd.


References

Directive 2000/54/EC of the European Parliament and Council of 18 September 2000 on the protection of workers from risks related to exposure to biological agents at work. EUR-Lex web site. https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=CELEX%3A32000L0054. Accessed May 2020.
Grimsey P, Frey N, Bendig G, et al. Population pharmacokinetics of exogenous biotin and the relationship between biotin serum levels and in vitro immunoassay interference. Int J Pharmacokinet. 2017;2(4):247-256.10.4155/ipk-2017-0013
Occupational Safety and Health Standards. Code of Federal Regulations: Bloodborne pathogens. (29 CFR Part 1910.1030). Federal Register web site. https://www.govinfo.gov/content/pkg/CFR-2019-title29-vol6/xml/CFR-2019-title29-vol6-sec1910-1030.xml. Accessed May 2020.
Piketty ML, Prie D, Sedel F, et al. High-dose biotin therapy leading to false biochemical endocrine profiles: validation of a simple method to overcome biotin interference. Clin Chem Lab Med. 2017 May 1;55(6):817-825.28222020
Su S, Wong G, Shi W, et al. Epidemiology, Genetic Recombination, and Pathogenesis of Coronaviruses. Trends Microbiol. 2016 Jun;24(6):490-502.27012512
Zhu N, Zhang D, Wang W, et al. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733.31978945

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
164068 SARS-CoV-2 Antibodies 94762-2 164069 SARS-CoV-2 Antibodies 94762-2

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